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Stock impact report

Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis

Sanofi - American Depositary Shares (SNY) 
US:NYSE Investor Relations: sanofi.com/en/investors
Company Research Source: GlobeNewswire
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activityTolebrutinib has the potential to be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in MSTolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES phase 3 study in adults with non-relapsing secondary progressive MS Paris, March 25, 2025. The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA dec Show less Read more
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